MPS2 console 5202260Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20634624522262), received between Mar 23, 2016 and Mar 23, 2016 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K041979); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2016Device Displays Incorrect Message

  THE INTERNATIONAL DISTRIBUTOR ((B)(6)) REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WITH THE MPS-2 CONSOLE. THE REPORT STATED THAT THE CONSOLE IN USE WAS DISPLAYING 3 DIFFERENT ERROR CODES DURING A RECENT PROCEDURE (EXACT DATE NOT PROVIDED). THE CODES WERE "EC 203/MOTOR STUCK AT BOTTOM," "ARREST IS DISABLED," "ARREST PUMP ERROR, PROCEED WITHOUT PUMP." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING SPECIFIC DETAILS ON THE ALLEGED EVENT WERE UNSUCCESSFUL. THE FACILITY HAS 2 CONSOLES AND THEY DID NOT IDENTIFY WHICH CONSOLE WAS INVOLVED IN THE COMPLAINT. AT THIS TIME IT IS UNKNOWN IF THE CONSOLE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. SEE ALSO MANUFACTURER REPORT 1649914-2016-00011 FOR SIMILAR INCIDENT WHICH OCCURRED AT ANOTHER FACILITY/CUSTOMER OF THE DISTRIBUTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5520910 ↗
• MalfunctionMar 23, 2016Device Displays Incorrect Message

  THE INTERNATIONAL DISTRIBUTOR ((B)(4)) REPORTED AN ISSUE ENCOUNTERED BY ONE OF THEIR CUSTOMERS WITH THE MPS-2 CONSOLE. THE REPORT STATED THAT THE CONSOLE IN USE WAS DISPLAYING 3 DIFFERENT ERROR CODES DURING A RECENT PROCEDURE (EXACT DATE NOT PROVIDED). THE CODES WERE "EC 203/MOTOR STUCK AT BOTTOM", "ARREST IS DISABLED," "ARREST PUMP ERROR, PROCEED WITHOUT PUMP." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING SPECIFIC DETAILS ON THE ALLEGED EVENT WERE UNSUCCESSFUL. THE FACILITY HAS 2 CONSOLES AND THEY DID NOT IDENTIFY WHICH CONSOLE WAS INVOLVED IN THE COMPLAINT. AT THIS TIME IT IS UNKNOWN IF THE CONSOLE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5520815 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041979. One submission often covers many models, so check the product and lot details in each record.

• Z-1924-2011 · Jul 29, 2010 · Terminated
  Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure